Cleared Traditional

K821830 - MI DAS 1000 AUTOMATIC SLIDE STAINER

K821830 is an FDA 510(k) clearance for MI DAS 1000 AUTOMATIC SLIDE STAINER, manufactured by Innovative Medical Systems, Inc.. The device is a Class 1 Hematology device with product code KPA cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K821830 · Innovative Medical Systems, Inc. · Hematology device
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Jul 1982
Decision
30d
Days
Class 1
Risk

K821830 is an FDA 510(k) clearance for the MI DAS 1000 AUTOMATIC SLIDE STAINER. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3800 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K821830

510(k) Number K821830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 22, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

KPA Device Classification - Class 1, General Controls

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KPA Slide Stainer, Automated

All 20
Devices cleared under the same product code (KPA) and FDA review panel - the closest regulatory comparables to K821830.
MIDAS II AUTOMATIC STAINER
K842077 · Innovative Medical Systems, Inc. · Jul 1984
WESCOR 7100 AEROSPRAY SLIDE STAINER
K833295 · Wescor, Inc. · Oct 1983
MIDAS 6000 AUTOMATIC STAINER
K832994 · Innovative Medical Systems, Inc. · Sep 1983
GUAMSTAINER
K811697 · Tomtec · Jul 1981
TECHNICON AUTOSLIDE STAINING/PROCESSING
K781598 · Technicon Instruments Corp. · Oct 1978
HEMATOLOGY SLIDE STAINER
K780637 · A. J. P. Scientific, Inc. · May 1978
K821830 · MI DAS 1000 AUTOMATIC SLIDE STAINER
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